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Managing Center Operations & Logistics | SPRAVATO® (esketamine) HCP

Complying With Controlled Substance Requirements

Because SPRAVATO® is a Schedule III controlled substance, your treatment center will require appropriate storage of SPRAVATO®.1

Staff protocols will need to be established for handling and disposal of SPRAVATO® as well, in accordance with federal and state laws and regulations.1

Learn more about disposal

Reference:

1. SPRAVATO® Prescribing Information. Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.

Considerations for Staffing & Treatment Space

With dosing and monitoring requirements for SPRAVATO®, it is important for treatment centers to consider appropriate use of staff and space

A treatment space can be a room or designated area within your practice. Considerations for creating a treatment space for SPRAVATO® include a:

  • Person reclining in chair red icon

    Chair in which a patient can comfortably sit for at least 2 hours during monitoring

  • Blood pressure red icon

    Blood pressure cuff and pulse oximeter

  • Stethoscope red icon

    Trained healthcare provider to monitor the patient

Examples of how a SPRAVATO® treatment space may be set up

Multiple treatment chairs per space

Chairs in waiting room

Single treatment chair per space

Two chairs next to a lamp

For illustrative purposes only. Not intended to represent a promise, guarantee, or legal advice by Janssen Pharmaceuticals, Inc., about practice efficiencies.

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Learn more about the SPRAVATO® REMS program requirements.

SPRAVATO® Dosing and Administration

Consider dosing and administration requirements for SPRAVATO® so you can manage your patients accordingly

TRD Dosing Schedule1

Induction and maintenance dosing for adult patients with treatment-resistant depression (TRD)

Designed to address your patients’ long-term needs, with frequency and dosing strength that are flexible and based on clinical judgment

TRD induction and maintenance dosing schedule for adult patients
  • SPRAVATO® must be taken with an oral antidepressant
  • SPRAVATO® is self-administered, only under the supervision of a healthcare provider
  • The starting dose of SPRAVATO® for TRD is 56 mg (2 devices)

*Evidence of therapeutic benefit should be evaluated at the end of the induction phase to determine need for continued treatment.

Dosing frequency should be individualized to the lowest frequency required to maintain remission/response.

As determined by the prescribing physician.

MDSI Dosing Schedule1

Four weeks of consistent dosing to serve your patients’ needs

Short-term dosing (4 weeks)
  • SPRAVATO® must be taken with an oral antidepressant
  • SPRAVATO® is self-administered, only under the supervision of a healthcare provider
  • The dose of SPRAVATO® for depressive symptoms in adults with MDSI is 84 mg (3 devices) throughout treatment

MSDI=depressive symptoms in adults with MDD with acute suicidal ideation or behavior.

After 4 weeks of treatment with SPRAVATO®, evidence of therapeutic benefit should be evaluated to determine need for continued treatment. Treatment beyond 4 weeks has not been systematically evaluated.

§Dosing may be reduced to 56 mg twice per week based on tolerability.

Administering SPRAVATO®

Before administration

Two animated healthcare professionals speaking with patient
  • Discuss the potential benefits, risks, and side effects, and the process of SPRAVATO® treatment, including a review of the patient’s health history
  • Explain the reasons for the observation period (e.g., checking blood pressure levels, changes in respiratory status, sedation, and dissociation)
  • Review the Boxed WARNINGS
  • Discuss the process and determination of readiness for release

Patients will need to know ahead of time that1:

  • They should avoid food for 2 hours and not drink liquids for 30 minutes prior to their visit
  • Each appointment will last at least 2 hours, including monitoring
  • They will not be permitted to drive themselves home, so they must arrange transportation after every treatment session
  • They cannot engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a motor vehicle or operating machinery, until the next day after a restful sleep
  • They will still be able to reach out to their referring HCP with any questions or concerns

Administration

Animated patient administering nasal spray in front of healthcare professional
  • Patients self-administer SPRAVATO® under the supervision of a trained healthcare provider
  • Patients should take a 5-minute rest between each device (2 devices for a 56-mg dose, or 3 devices for an 84-mg dose)

Monitoring and discharge

Animated healthcare professional taking blood pressure of patient
  • Patients must be observed by a healthcare provider for at least 2 hours, until the healthcare provider determines the patient is safe to leave
  • Blood pressure must be assessed prior to and approximately 40 minutes after dosing with SPRAVATO®, and subsequently as clinically warranted until values decline
  • Monitor patients for changes in respiratory status, including pulse oximetry
  • Provide patient education in accordance with the SPRAVATO® Medication Guide and Prescribing Information
  • Ensure patient has arranged transportation home following treatment with SPRAVATO®
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Read the full Prescribing Information and Dosing and Administration Guide for administration instructions and post-administration observation requirements.

Reference:

1. SPRAVATO® Prescribing Information. Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.

Appointment Scheduling

Patients must be informed that SPRAVATO® treatment requires a series of frequent appointments.

Example of SPRAVATO dosing frequency over time1

Starting new adult patients on SPRAVATO® for TRD requires 2 appointments weekly for the first 4 weeks of treatment (the induction phase). If treatment continues, appointments will be once weekly for weeks 5 to 8, then every 2 weeks or once weekly thereafter. 1*

TRD=treatment-resistant depression in adults.

*For weeks 9 and after, administer SPRAVATO® every 2 weeks or once weekly (56 mg or 84 mg). Dosing frequency should be individualized to the least frequent dosing to maintain remission/response.
After 4 weeks of treatment with SPRAVATO®, evidence of therapeutic benefit should be evaluated to determine need for continued treatment.
For illustrative purposes only and not intended to represent a promise, guarantee, or legal advice by Janssen Pharmaceuticals, Inc., about practice efficiencies.

Four weeks of consistent dosing, requiring 2 appointments weekly

MDSI=depressive symptoms in adults with MDD with acute suicidal ideation of behavior.

After 4 weeks of treatment with SPRAVATO®, evidence of therapeutic benefit should be evaluated to determine need for continued treatment. Treatment beyond 4 weeks has not been systematically evaluated.
For illustrative purposes only and not intended to represent a promise, guarantee, or legal advice by Janssen Pharmaceuticals, Inc., about practice efficiencies.

A staggered SPRAVATO® treatment schedule can allow 1 clinical staff member or physician to manage multiple patients simultaneously1*

Staggered dosing schedule of treatment chair 1 and 2

Example of staff and chair use when offering SPRAVATO®.

  • Treatment centers and clinicians should determine the appropriate number of chairs per treatment space

*These times may vary by patient and by whether this is the patient’s first treatment session or a subsequent treatment session. Additional monitoring beyond 2 hours and discharge are up to clinician judgment.

Assess blood pressure prior to administration and wait 5 minutes after each device to allow medication to fully absorb. Patient may use up to 3 devices, which may require up to 15 minutes.

Blood pressure is assessed prior to and approximately 40 minutes after dosing with SPRAVATO®, and subsequently as clinically warranted until values decline.

§Patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting. Instruct patients not to engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a motor vehicle or operating machinery, until the next day following a restful sleep.
For illustrative purposes only and not intended to represent a promise, guarantee, or legal advice by Janssen Pharmaceuticals, Inc., about practice efficiencies.

Reference:

1. SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.

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Ask your Janssen representative about the SPRAVATO® Operational Considerations Tool. The tool can help your practice understand resource capacity to help plan for SPRAVATO® treatment based on your number of patients, available treatment chairs, and time required for treatment and monitoring.

Packaging & Storage1

Packaging

SPRAVATO® is available in the following presentations:

56 mg dose kit packaging
84 mg dose kit packaging

Storage

  • Once SPRAVATO® is delivered for a named patient or is acquired in bulk supply, it must be kept in a secure place per state and federal regulations
  • Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F)
  • Product dispensed for a specific named patient must be administered within 14 days after receipt by the healthcare setting

Reference:

1. SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.

Disposal

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Used Devices

Once the SPRAVATO® device has been used by the patient, it should be disposed of as medical waste according to local, state, and federal regulations for controlled substances.

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Unused Devices

After 14 days, unused named-patient products must be appropriately disposed of according to state and federal regulations and may not be returned to the general inventory of the healthcare setting or pharmacy.

WHAT IS IT?

  • Janssen has partnered with the SPRAVATO® Disposal Program, a reverse distribution company, to support the safe return and destruction of partially used or unused dispensed patient-labeled products, at no cost to the healthcare provider

WHEN TO USE IT?

  • If you have partially used devices—meaning the patient received 1 spray and then either the patient or the healthcare provider decided not to continue with treatment
  • If a pharmacy dispensed patient-labeled product to your healthcare setting and the patient was not treated with SPRAVATO® within 14 days of receipt

HOW TO USE IT?

  • You can utilize the SPRAVATO® Disposal Program by calling 888-912-7348

WHAT CAN YOU EXPECT?

  • When you call the SPRAVATO® Disposal Program, they will capture your name, practice name, address, DEA#, reason for disposal, # of units, NDC and description, lot #, and expiration date and send you a pre-populated packing slip (shipping label)
  • Package the device and send via UPS Ground Transportation using the packing slip provided by the SPRAVATO® Disposal Program
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Partially Used Devices

If the patient received 1 spray and then either the patient or the healthcare provider decided not to continue with treatment, the partially used product must be disposed of.

Contact the SPRAVATO® Disposal Program to dispose of unused or partially used devices if your healthcare setting is not equipped to do so. Simply call 888-912-7348.

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Expired Product

If the product is past the expiration date printed on the box and blister pack, coordinate with the pharmacy that sent you the expired product to exchange it for new product.

If you purchased the product from a distributor or wholesaler, you can learn about the returns process and eligibility criteria by calling INMAR® at 800-967-5952, or click here to review Janssen’s Returns Policy.

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Handling Device Malfunctions

If the device has prematurely expelled medication—or won’t expel medication—then a healthcare provider should call Janssen Medical Information at 800-JANSSEN to report a product quality complaint.

The Medical Information team will assist in taking the complaint submission. Your staff must then determine how to obtain more product to prevent the patient from missing doses (if possible) and follow the process for returning the device.